Application for Radioactive Material License for Medical Use



APPLICATION FOR RADIOACTIVE MATERIAL LICENSE FOR MEDICAL USEThe Wisconsin Department of Health Services (DHS) is requesting disclosure of all information on this application for the purpose of obtaining a radioactive material license. Failure to provide any information may result in denial or delay of a radioactive material license.Instructions: Complete all items if this is an initial application or an application for renewal of a license. Refer to WISREG “Guidance for Medical Use of Radioactive Material.” Use supplementary sheets where necessary. Retain one copy and submit original of the entire application to DHS, P.O. Box 2659, Madison, WI 53701-2659APPLICATION TYPEItem 1. Type Of Application (Check one box) FORMCHECKBOX New License FORMCHECKBOX Renewal, License Number CONTACT INFORMATIONItem 2. Name and Mailing Address of Applicant FORMTEXT ????? FORMTEXT ????? FORMTEXT ????? FORMTEXT ?????, FORMTEXT ?? FORMTEXT ????? - FORMTEXT ????Item 3. Person to contact regarding this application FORMTEXT ?????Applicant's Telephone Number (Include Area Code) ( FORMTEXT ???) FORMTEXT ???- FORMTEXT ???? x FORMTEXT ?????Contact’s Telephone Number (Include Area Code) ( FORMTEXT ???) FORMTEXT ???- FORMTEXT ???? x FORMTEXT ?????LOCATION OF RADIOACTIVE MATERIALItem 4. Address(es) Where Radioactive Material Will Be Used Or Possessed (Do not use P.O. Box)Address FORMTEXT ????? FORMTEXT ????? FORMTEXT ?????, FORMTEXT ?? FORMTEXT ?????- FORMTEXT ????Telephone Number (Include area code)( FORMTEXT ???) FORMTEXT ???- FORMTEXT ???? x FORMTEXT ?????Address FORMTEXT ????? FORMTEXT ????? FORMTEXT ?????, FORMTEXT ?? FORMTEXT ?????- FORMTEXT ????Telephone Number (Include area code)( FORMTEXT ???) FORMTEXT ???- FORMTEXT ???? x FORMTEXT ?????Address FORMTEXT ????? FORMTEXT ????? FORMTEXT ?????, FORMTEXT ?? FORMTEXT ?????- FORMTEXT ????Telephone Number (Include area code)( FORMTEXT ???) FORMTEXT ???- FORMTEXT ???? x FORMTEXT ?????Address FORMTEXT ????? FORMTEXT ????? FORMTEXT ?????, FORMTEXT ?? FORMTEXT ?????- FORMTEXT ????Telephone Number (Include area code)( FORMTEXT ???) FORMTEXT ???- FORMTEXT ???? x FORMTEXT ?????Is radioactive material used at other off-site locations? FORMCHECKBOX Yes FORMCHECKBOX NoIf yes, attach an additional sheet(s) with the address(es) and a list of activities to be conducted at each location of use.INDIVIDUAL(S) RESPONSIBLE FOR RADIATION SAFETY Item 5.1 Radiation Safety Officer (RSO) (Check all that apply and attach evidence of training and experience) FORMCHECKBOX We will provide the name of the proposed RSO and other potential designees who will be responsible for ensuring that the licensee’s radiation safety program is implemented in accordance with approved procedures. We will provide documentation showing delegation of authority to the Radiation Safety Officer.Name: Telephone Number (Include Area Code) ( FORMTEXT ???) FORMTEXT ???- FORMTEXT ???? x FORMTEXT ?????AND ONE OF THE FOLLOWING FORMCHECKBOX We will provide the previous license number (if issued by DHS) or a copy of the license (if issued by the NRC or an Agreement State) that authorized the uses requested and on which the individual was specifically named as the RSO.OR FORMCHECKBOX We will provide a copy of the certification(s) for the board(s) approved by DHS and as applicable to the types of use for which he or she has RSO responsibility.ANDWe will provide a written attestation, signed by a preceptor RSO, that the above training and experience as specified in s. DHS 157.61 (7) has been satisfactorily completed and that the individual has achieved a level of radiation safety knowledge sufficient to independently function as a RSO. See Appendix B of WISREG “Guidance for Medical Use of Radioactive Material” for a form that may be used for this purpose.OR FORMCHECKBOX We will provide a description of the training and experience specified in s. DHS 157.61(7)(b) demonstrating that the proposed RSO is qualified by training and experience as applicable to the types of use for which he or she has RSO responsibilities. See Appendix B of WISREG “Guidance for Medical Use of Radioactive Material” for a form that may be used for this purpose.ANDWe will provide a written attestation, signed by a preceptor RSO, that the above training and experience as specified in s. DHS 157.61 (7) has been satisfactorily completed and that the individual has achieved a level of radiation safety knowledge sufficient to independently function as a RSO. See Appendix B of WISREG “Guidance for Medical Use of Radioactive Material” for a form that may be used for this purpose.AND, IF APPLICABLE FORMCHECKBOX We will provide a description of recent related continuing education and experience as required by s. DHS 157.61(11). Item 5.2 Authorized Users (AU) (Check all that apply and attach evidence of training and experience) FORMCHECKBOX We will attach a list of each proposed authorized user with the types and quantities of licensed material to be used.AND ONE OF THE FOLLOWING FOR EACH AU FORMCHECKBOX We will provide the previous license number (if issued by DHS) or a copy of the license (if issued by the NRC or an Agreement State) on which the physician was specifically named as an AU for the uses requested. OR FORMCHECKBOX We will provide a copy of the certification(s) for the board(s) approved by DHS and as applicable to the use requested.ANDWe will provide a written attestation, signed by a preceptor AU, that the training and experience as specified in s. DHS 157 .63(4)(c); 157.63(5)(c); 157.64(4)(b); 157.65(5)(c); 157.65(6)(c); 157.65(8)(b); 157.65(9); or 157.67(17)(b), as applicable, has been satisfactorily completed and that the individual has achieved a level of competency sufficient to function independently as an authorized user. See Appendix B of WISREG “Guidance for Medical Use of Radioactive Material” for a form that may be used for this purpose.OR FORMCHECKBOX We will provide a description of the training and experience as specified in s. DHS 157.63(4)(c); 157.63(5)(c); 157.64(4)(b); 157.65(5)(c); 157.65(6)(c); 157.65(8)(b); 157.65(9); 157.66(b); or 157.67(17)(b), as applicable, demonstrating that the proposed AU is qualified by training and experience for the use requested. See Appendix B of WISREG “Guidance for Medical Use of Radioactive Material” for a form that may be used for this purpose.ANDWe will provide a written attestation, signed by a preceptor AU, that the above training and experience as specified in s. DHS 157 .63(4)(c); 157.63(5)(c); 157.64(4)(b); 157.65(5)(c); 157.65(6)(c); 157.65(8)(b); 157.65(9); or 157.67(17)(b), as applicable, has been satisfactorily completed and that the individual has achieved a level of competency sufficient to function independently as an authorized user. See Appendix B of WISREG “Guidance for Medical Use of Radioactive Material” for a form that may be used for this purpose.AND, IF APPLICABLE FORMCHECKBOX We will provide a description of recent related continuing education and experience as required by s. DHS 157.61(11).Item 5.3 Authorized Nuclear Pharmacist (ANP) (Check all that apply and attach evidence of training and experience) FORMCHECKBOX Not applicable FORMCHECKBOX We will provide the name(s) of the authorized nuclear pharmacist(s).Name Telephone Number (Include Area Code) ( FORMTEXT ???) FORMTEXT ???- FORMTEXT ???? x FORMTEXT ?????AND ONE OF THE FOLLOWING FOR EACH ANP FORMCHECKBOX We will provide the previous license number (if issued by DHS) or a copy of the license (if issued by the NRC or an Agreement State) on which the individual was specifically named ANP. OR FORMCHECKBOX We will provide a copy of the certification(s) for the radiopharmacy board(s) approved by DHS.ANDWe will provide a written attestation, signed by a preceptor ANP, that the training and experience as specified in s. DHS 157.61(9) has been satisfactorily completed and that the individual has achieved a level of competency sufficient to function independently as an authorized nuclear pharmacist. See Appendix B of WISREG “Guidance for Medical Use of Radioactive Material” for a form that may be used for this purpose.OR FORMCHECKBOX We will provide a description of the training and experience specified in s. DHS 157.61(9)(b) demonstrating that the proposed ANP is qualified by training and experience. See Appendix B of WISREG “Guidance for Medical Use of Radioactive Material” for a form that may be used for this purpose.ANDWe will provide a written attestation, signed by a preceptor ANP, that the training and experience as specified in s. DHS 157.61(9) has been satisfactorily completed and that the individual has achieved a level of competency sufficient to function independently as an authorized nuclear pharmacist. See Appendix B of WISREG “Guidance for Medical Use of Radioactive Material” for a form that may be used for this purpose.AND, IF APPLICABLE FORMCHECKBOX We will provide a description of recent related continuing education and experience as required by s. DHS 157.61(11).Item 5.4 Authorized Medical Physicist (AMP) (Check all that apply and attach evidence of training and experience) FORMCHECKBOX Not applicableCOMPLETE ONLY IF REQUESTING LICENSE AUTHORIZATION FOR:HDR, GAMMA STEREOTACTIC RADIOSURGERY UNIT, TELETHERAPY OR OPHTHALMIC USE FORMCHECKBOX We will provide the name(s) of the authorized medical physicist(s).Name: TELEPHONE (Include Area Code): ( FORMTEXT ???) FORMTEXT ???- FORMTEXT ???? x FORMTEXT ?????AND ONE OF THE FOLLOWING FOR EACH AMP FORMCHECKBOX We will provide the previous license number (if issued by DHS) or a copy of the license (if issued by the NRC or an Agreement State) on which the individual was specifically named AMP. OR FORMCHECKBOX We will provide a copy of the certification(s) for the board(s) approved by DHS.ANDWe will provide a written attestation, signed by a preceptor AMP, that the training and experience as specified in s. DHS 157.61(8) has been completed and the individual has achieved a level of competency sufficient to function independently as an authorized medical physicist. See Appendix B of WISREG “Guidance for Medical Use of Radioactive Material” for a form that may be used for this purpose.OR FORMCHECKBOX We will provide a description of the training and experience specified in s. DHS 157.61(8)(b) demonstrating that the proposed AMP is qualified by training and experience. See Appendix B of WISREG “Guidance for Medical Use of Radioactive Material” for a form that may be used for this purpose.ANDWe will provide a written attestation, signed by a preceptor AMP, that the above training and experience as specified in s. DHS 157.61(8) has been completed and the individual has achieved a level of competency sufficient to function independently as an authorized medical physicist. See Appendix B of WISREG “Guidance for Medical Use of Radioactive Material” for a form that may be used for this purpose.AND, IF APPLICABLE FORMCHECKBOX We will provide a description of recent related continuing education and experience as required by s. DHS 157.61(11).TRAINING FOR WORKERSItem 6 Training For Individuals Working In Or Frequenting Restricted Areas (Check one box) FORMCHECKBOX We will follow the training programs described in Appendix H of WISREG “Guidance for Medical Uses of Radioactive Material”.OR FORMCHECKBOX We will develop and implement and maintain a training program that will meet the criteria in the section titled ‘Training for Individuals Working in or Frequenting Restricted Areas’ of WISREG “Guidance for Medical Use of Radioactive Material.” (Description is attached)RADIOACTIVE MATERIALItem 7.1 Purpose(s) For Which Licensed Radioactive Material Will Be Used. (Attach additional pages if necessary)Type of Use – Check Box if Use is DesiredChemical and Physical FormMaximum Amount(Curies)Sealed Source Device Registration Sheet NumberSealed Source Manufacturer or Distributor Model NumberDevice Manufacturer or Distributor Model NumberUse of Radioactive Material for Certain In-Vitro Clinical or laboratory testing if maximum activity exceeds 200 Cis. DHS 157.11 (2) (f) FORMCHECKBOX AnyAs neededN/AN/AN/AUse of Calibration, Transmission, and Reference Sources not included in s. DHS 157.62 (4) (e.g., bone densitometry sources, fluorine-18 calibration sources) FORMCHECKBOX Attach a detailed description of the radioactive material and intended use.N/AN/AN/A Unsealed Radioactive Material for Uptake, Dilution and Excretion Studies for Which a Written Directive is not Requireds. DHS 157.63 (1) FORMCHECKBOX AnyAs neededN/AN/AN/A Unsealed Radioactive Material for Imaging and Localization Studies for Which a Written Directive is not Requireds. DHS 157.63 (2) FORMCHECKBOX AnyAs neededN/AN/AN/AUnsealed Radioactive Material for Which a Written Directive is Requireds. DHS 157.64 (1) FORMCHECKBOX Any FORMTEXT ?????N/AN/AN/AUnsealed Radioactive Material for Which a Written Directive is RequiredSpecific radiopharmaceuticalss. DHS 157.64 (1) FORMCHECKBOX For this type of use attach adetailed description ofradiopharmaceutical, form,route of administration andtherapeutic use.N/AN/AN/A Sources for Manual Brachytherapys. DHS 157.65 (1) FORMCHECKBOX Sealed Source FORMTEXT ????? FORMTEXT ????? FORMTEXT ????? FORMTEXT ?????Type of Use – Check Box if Use is DesiredChemical and Physical FormMaximum Amount(Curies)Sealed Source Device Registration Sheet NumberSealed Source Manufacturer or Distributor Model NumberDevice Manufacturer or Distributor Model NumberSources for Manual Brachytherapy – Ophthalmic Use Onlys. DHS 157.65 (1) FORMCHECKBOX Sealed Source FORMTEXT ????? FORMTEXT ????? FORMTEXT ????? FORMTEXT ?????Sealed Sources for Diagnosiss. DHS 157.66 (1) FORMCHECKBOX Sealed Source FORMTEXT ????? FORMTEXT ????? FORMTEXT ????? FORMTEXT ?????Sealed Source(s) in a Device for Therapy – Teletherapy Units. DHS 157.67 (1) FORMCHECKBOX Sealed Source FORMTEXT ????? FORMTEXT ????? FORMTEXT ????? FORMTEXT ?????Sealed Source(s) in a Device for Therapy – Remote Afterloader Units. DHS 157.67 (1) FORMCHECKBOX Sealed Source FORMTEXT ????? FORMTEXT ????? FORMTEXT ????? FORMTEXT ????? Sealed Source(s) in a Device for Therapy – Gamma Stereotactic Radiosurgery Units. DHS 157.67 (1) FORMCHECKBOX Sealed Source FORMTEXT ????? FORMTEXT ????? FORMTEXT ????? FORMTEXT ?????Other Medical Use of Radioactive Material or Radiation from Radioactive Material ( e.g. Emerging Technology)s. DHS 157.70 FORMCHECKBOX For this type of use attach adetailed description of theradioactive material andintended use FORMTEXT ????? FORMTEXT ????? FORMTEXT ?????Non-medical use of radioactive material FORMCHECKBOX Attach a detailed description of the radioactive material and intended use. FORMTEXT ????? FORMTEXT ????? FORMTEXT ?????Item 7.2 Recordkeeping for Decommissioning and Financial AssuranceThe applicant is not required to submit proof of recordkeeping for decommissioning and financial assurance during the licensing phase. This matter will be examined during an inspection. FACILITIES AND EQUIPMENTItem 8.1 Facilities Diagram (Check box and attach requested information.) FORMCHECKBOX We will submit the information in the section titled ‘Facilities Diagram’ in WISREG “Guidance for Medical Use of Radioactive Material.”Item 8.2 Radiation Monitoring Instruments (Check all that apply) FORMCHECKBOX We will identify the instrument type, sensitivity, range for each type of radiation detected and state whether the instrument will be used for ‘measuring’ or ‘detection’. Additionally if only one survey instrument is to be used we will describe what is done when the survey instrument is being calibrated or repaired. AND FORMCHECKBOX We reserve the right to upgrade our survey instruments as necessary as long as they are adequate to measure the type and level of radiation for which they are used.AND FORMCHECKBOX We will provide a description of the instrumentation (e.g. gamma counter, solid state detector, portable or stationary count rate meter, portable or stationary dose rate or exposure rate meter, single or multichannel analyzer, liquid scintillation counter, proportional counter) that will be used to perform required surveys or leak testing and analysis.AND ONE OF THE FOLLOWING FORMCHECKBOX We will use radiation monitoring instruments that will be calibrated by a person authorized by DHS, the NRC or an Agreement State to perform survey meter calibrations.OR FORMCHECKBOX We will follow survey meter calibration procedures in accordance with Appendix I of WISREG “Guidance for Medical Use of Radioactive Material.” Item 8.3 Dose Calibrator And Other Equipment Used To Measure Dosages Of Unsealed Radioactive Material (Check all that apply) FORMCHECKBOX Not applicable. (Will only use unit doses or no unsealed radioactive material use)OR FORMCHECKBOX We will identify the instrument type, manufacturer, and model number. Additionally, if only one dose calibrator is possessed, we will describe what is done when the dose calibrator is being calibrated or repaired.AND FORMCHECKBOX Equipment used to measure dosages will be calibrated in accordance with nationally recognized standards or the manufacturer’s instructions. AND IF REQUESTING AUTHORIZATION FOR DHS 157.64(1) MATERIAL, FORMCHECKBOX Beta-emitting radiopharmaceuticals will be ordered and administered as unit doses only.OR FORMCHECKBOX Procedures for verifying the activity of beta-emitting radiopharmaceuticals in a dose calibrator are attached. Item 8.4 Dosimetry Equipment – Calibration And Use (Check all that apply)COMPLETE THIS SECTION ONLY IF REQUESTING LICENSE AUTHORIZATION FOR:HDR, GAMMA STEREOTACTIC RADIOSURGERY UNIT, TELETHERAPY OR BRACHYTHERAPY USE FORMCHECKBOX We will calibrate dosimetry equipment in accordance with the requirements in s. DHS 157.67 (6).AND FORMCHECKBOX We have developed and will implement a written calibration procedure for a therapy sealed source that meets the requirements ins. DHS 157.65 (6) and s. DHS 157.67 (6-12) (as applicable to the type of medical use requested).AND FORMCHECKBOX We will identify the dosimetry system, manufacturer and model number. Item 8.5 Other Equipment And Facilities (Check box and attach requested information) FORMCHECKBOX A detailed description of additional equipment and facilities available for the safe use and storage of radioactive materials requested is attached.RADIATION PROTECTION PROGRAMItem 9.1 Audit ProgramThe applicant is not required to submit its audit program to DHS for review during the licensing phase. This matter will be examined during an inspection. Item 9.2 Occupational Dose (Check all that apply) FORMCHECKBOX We will provide a description of facilities and equipment used for monitoring occupational exposure. (Description is attached)AND ONE OF THE FOLLOWING FORMCHECKBOX We will follow the procedures in Appendix L of WISREG “Guidance for Medical Use of Radioactive Material” for monitoring occupational dose. OR FORMCHECKBOX We have developed and will implement written procedures for monitoring occupational dose in accordance with s. DHS 157.21 and that meets the requirements in Chapter DHS 157 “Radiation Protection”, Subchapter III “Standards for Protection from Radiation”. (Procedures are attached)Item 9.3 Public Dose No response is required in this license application; however, the licensee’s evaluation of public dose will be examined during an inspection.Item 9.4 Minimization Of Contamination (Check one box) FORMCHECKBOX We will follow the cleanup procedures from Appendix R, Tables 9 and 10, of WISREG "Guidance for Medical Use of Radioactive Material" to minimize the amount of radioactive contamination and radioactive waste generated at our facility.OR FORMCHECKBOX We will develop, implement and maintain procedures to minimize the amount of radioactive contamination and radioactive waste generated at our facility. (Procedures are attached.)Item 9.5 Operating And Emergency Procedures No response is required in this license application; however, the licensee’s operating and emergency procedures will be examined during an inspection.Item 9.6 Material Receipt And Accountability (Check one box) FORMCHECKBOX Physical inventories will be conducted at intervals not to exceed 6 months, to account for all sealed sources and devices received and possessed under the license.OR FORMCHECKBOX We will submit a description of the frequency and procedures for ensuring that no radioactive material has been lost, stolen or misplaced (Procedures are attached). Item 9.7 Ordering And Receiving (Check one box) FORMCHECKBOX We will develop, implement and maintain ordering and receiving procedures that will meet the criteria in the section entitled ‘Ordering and Receiving’ of WISREG “Guidance for Medical Use of Radioactive Material.” (Procedures are attached)OR FORMCHECKBOX We will follow procedures for ordering and receiving in accordance with Appendix O of WISREG “Guidance for Medical Use of Radioactive Material.”Item 9.8 Opening Packages No response is required in this license application; however, the licensee’s package opening procedure will be examined during an inspection.Item 9.9 Leak Test (Check one box) FORMCHECKBOX Leak tests will be performed by an organization authorized by DHS, the NRC or an Agreement State to provide leak testing services to other licensees; or by using a leak test kit supplied by an organization licensed by DHS, the NRC or an Agreement State to provide leak test kits to other licensees according to kit suppliers' instructions.List the name and license number of organization authorized to perform or analyze leak test (Specify whether DHS, NRC, or other Agreement State):Organization Name: License Number: Note: An alternate organization may be used to perform or analyze leak test, without amending the license, provided the organization is specifically authorized by DHS, the NRC or an Agreement State. OR FORMCHECKBOX We will perform our own leak testing and sample analysis. We will follow the procedures in Appendix Q of WISREG “Guidance for Medical Use of Radioactive Material.” OR FORMCHECKBOX We will submit alternative procedures. (Procedures are attached)Item 9.10 Area Surveys (Check one box) FORMCHECKBOX We will develop, implement and maintain procedures for area surveys that will meet the criteria in the section titled ‘Area Surveys’ in WISREG “Guidance for Medical Use of Radioactive Material.” (Procedures are attached)OR FORMCHECKBOX We will follow the procedures for area survey in Appendix R of WISREG “Guidance for Medical Use of Radioactive Material.”Item 9.11 Procedures For Administration of Radioactive Material Requiring A Written Directive (Check one box) FORMCHECKBOX We will develop, implement and maintain procedures for administration of radioactive material requiring a written directive that will meet the criteria in the section entitled ‘Procedures for Administrations Requiring a Written Directive’ in WISREG “Guidance for Medical Use of Radioactive Material.” OR FORMCHECKBOX Not Applicable. Item 9.12 Safe Use Of Unsealed Radioactive Material (Check one box) FORMCHECKBOX We will develop, implement and maintain procedures for the safe use of unsealed radioactive material that will meet the criteria in the section titled ‘Safe Use of Unsealed Radioactive Material’ in WISREG “Guidance for Medical Use of Radioactive Material.” (Procedures are attached)OR FORMCHECKBOX We will follow the procedures for the safe use of unsealed radioactive material in Appendix T of WISREG “Guidance for Medical Use of Radioactive Material.”OR FORMCHECKBOX Not Applicable.Item 9.13 Maintenance Of Therapy Devices Containing Sealed Sources (Check all that apply) FORMCHECKBOX Not Applicable. (No therapy devices containing sealed sources)OR FORMCHECKBOX We will contract with personnel who are licensed by DHS, the NRC or an Agreement State to perform maintenance and repair services on the specific therapy device(s) possessed by the licensee.OR THE FOLLOWING THREE CONDITIONS MUST BE MET FORMCHECKBOX We will name the proposed employee or employees and types of maintenance and repair requested.AND FORMCHECKBOX We will provide a description of the training and experience demonstrating that the proposed employee or employees is/are qualified by training and experience for the use requested.AND FORMCHECKBOX We will provide a copy of the manufacturer’s training certification and an outline of the training.Item 9.14 Spill Procedures (Check one box) FORMCHECKBOX We will develop, implement and maintain procedures for response to spills of radioactive material. (Procedures are attached.)OR FORMCHECKBOX We will follow procedures for response to spills of radioactive material in accordance with Appendix N of WISREG "Guidance for Medical Use of Radioactive Material". OR FORMCHECKBOX Not Applicable. (Unsealed radioactive material not used)Item 9.15 Emergency Response For Sealed Sources Or Devices Containing Sealed Sources (Check one box) FORMCHECKBOX We will develop, implement and maintain procedures for emergency response for sealed sources or devices containing sealed sources. (Procedures are attached)OR FORMCHECKBOX Not Applicable. (Brachytherapy sources, high activity sealed sources or devices containing sealed sources not used)Item 9.16 Release of Patients Or Human Research Subjects (Check one box) FORMCHECKBOX We will develop, implement and maintain procedures for release of patients or human research subjects that will meet the criteria in the section titled ‘Release of Patients or Human Research Subjects’ in WISREG “Guidance for Medical Use of Radioactive Material.” (Procedures are attached)OR FORMCHECKBOX We will follow the procedures for release of patients or human research subjects in Appendix U of WISREG “Guidance for Medical Use of Radioactive Material.”OR FORMCHECKBOX Not applicable. (Studies only performed under s. DHS 157.63(1) & (2))Item 9.17 Mobile Medical Service (Check one box) FORMCHECKBOX We will provide the information requested, along with any procedures mentioned in Appendix V of WISREG “Guidance for Medical Use of Radioactive Material.” (Procedures are attached)OR FORMCHECKBOX Not applicable.Item 9.18 Transportation No response is needed during the license process; this issue will be reviewed during inspection. Note: Before offering a Type B package for shipment, a licensee needs to have registered as a user of the package and obtained the departments approval of its QA Program. Alternatively, the licensee may choose to transfer possession of radioactive material to a manufacturer (or distributor) (or service licensee) with a DHS, NRC or agreement state license who then acts as the shipper.Item 9.19 Sealed Source InventoryItem 9.20 Records of Dosages and Use of Brachytherapy SourceItem 9.21 Safety Procedures For Treatments Where Patients Are HospitalizedItem 9.22 RecordkeepingItem 9.23 ReportingNo response is needed during the licensing process; these issues will be reviewed during inspection.WASTE MANAGEMENTItem 10 Waste Management (Check all that apply) FORMCHECKBOX We will follow the waste procedures published in Appendix X of WISREG “Guidance for Medical Use of Radioactive Material.”AND / OR FORMCHECKBOX We will dispose of liquids into sanitary sewerage. (Procedures are attached) OR FORMCHECKBOX We will provide procedures for waste collection, storage and disposal by any of the authorized methods described in Item 10 ‘Waste Management’ of WISREG “Guidance for Medical Use of Radioactive Material.” We will contact DHS for guidance to obtain approval of any method(s) of waste disposal other than those discussed in Item 10 ‘Waste Management’ of WISREG "Guidance for Medical Use of Radioactive Material.” (Procedures are attached)FeesItem 11 License Fees (Refer To Wisconsin Administration Code DHS 157.10)Category: FORMTEXT ?????Application Fee Enclosed (For new applications only): FORMCHECKBOX Yes FORMCHECKBOX No Amount Enclosed: $ CERTIFICATION (To be signed by an individual authorized to make binding commitments on behalf of the applicant.)Item 12I hereby certify that this application was prepared in conformance with Chapter DHS 157 “Radiation Protection” and that all information contained herein, including any supplements attached hereto, is true and correct to the best of my knowledge and belief.SIGNATURE - Applicant Or Authorized IndividualDate signed FORMTEXT ?????Print Name and Title of above signatory FORMTEXT ?????OPTIONAL: CORRESPONDENCE AUTHORITYI have delegated correspondence authority for matters pertaining to our Radioactive Materials License to ________ FORMTEXT ?????____________. The designee named here has approval to submit amendment requests concerning this Radioactive Materials License. I understand that license renewal applications must be signed by a member of upper management.SIGNATURE - Applicant Or Authorized IndividualDate signed FORMTEXT ????? ................
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